01 12Delta Synthetic Co., Ltd.
02 1Swati Spentose Private Limited (Unit-I)
01 1Ace Biopharm Co., Ltd.
02 2Daeshin Pharmaceutical Co., Ltd.
03 1Essel Bio Co., Ltd.
04 1Hiple Co., Ltd.
05 1Hoosung Bio Co., Ltd.
06 1Hwail Pharmaceutical Co., Ltd.
07 1IMCD Korea Co., Ltd.
08 1Insung Trading Co., Ltd.
09 1SG Biochem Co., Ltd.
10 1SPC Co., Ltd.
11 1Wonpung Pharmaceutical Co., Ltd.
12 1Youngjin Pharmaceutical Co., Ltd.
01 13Lidocaine hydrochloride
01 1India
02 12Taiwan
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2021-11-24
Registration Number : 20210309-210-J-704(5)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15 Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-07-15
Registration Number : 20210309-210-J-704(4)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15, Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2021-07-14
Registration Number : 20210309-210-J-704(2)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15, Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-07-14
Registration Number : 20210309-210-J-704(3)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15, Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
Registrant Name : Hiple Co., Ltd.
Registration Date : 2024-06-28
Registration Number : 20210309-210-J-704(11)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15 Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
Registrant Name : SPC Co., Ltd.
Registration Date : 2022-06-20
Registration Number : 20210309-210-J-704(8)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15, Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
Registrant Name : Hoosung Bio Co., Ltd.
Registration Date : 2023-11-20
Registration Number : 20210309-210-J-704(10)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15, Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
Registrant Name : Essel Bio Co., Ltd.
Registration Date : 2023-11-20
Registration Number : 20210309-210-J-704(9)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15, Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
Registrant Name : Wonpung Pharmaceutical Co., Ltd.
Registration Date : 2022-05-17
Registration Number : 20210309-210-J-704(7)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15, Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2021-12-17
Registration Number : 20210309-210-J-704(6)
Manufacturer Name : Delta Synthetic Co., Ltd.
Manufacturer Address : 15, Minsheng St., Tucheng Dist., New Taipei City 23679, Taiwan, ROC
A Xylocaine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xylocaine, including repackagers and relabelers. The FDA regulates Xylocaine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xylocaine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Xylocaine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xylocaine supplier is an individual or a company that provides Xylocaine active pharmaceutical ingredient (API) or Xylocaine finished formulations upon request. The Xylocaine suppliers may include Xylocaine API manufacturers, exporters, distributors and traders.
click here to find a list of Xylocaine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Xylocaine Drug Master File in Korea (Xylocaine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xylocaine. The MFDS reviews the Xylocaine KDMF as part of the drug registration process and uses the information provided in the Xylocaine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Xylocaine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Xylocaine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Xylocaine suppliers with KDMF on PharmaCompass.
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